Catalog Number

-

Brand Name

CLASSIC-CUF

Version/Model Number

CLA-A2-2A-X-5S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K120125,K120125

Product Code

DXQ

Product Code Name

blood pressure cuff

Public Device Record Key

001d39f9-0994-4c30-b3bd-4fa9761a7a09

Public Version Date

August 10, 2021

Public Version Number

1

DI Record Publish Date

August 02, 2021

Package DI Number

00195278197160

Quantity per Package

20

Contains DI Package

00195278025296

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pack